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Trial registered on ANZCTR


Registration number
ACTRN12618001166268
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
13/07/2018
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is there a synergistic effect of adding social cognition remediation to cognitive remediation therapy in young people? A randomised controlled trial
Scientific title
Is there a synergistic effect of adding social cognition remediation to cognitive remediation therapy in young people? A randomised controlled trial
Secondary ID [1] 294841 0
Nil Known
Universal Trial Number (UTN)
U1111-1214-1385
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive deficits 307866 0
Social deficits 307867 0
Condition category
Condition code
Mental Health 306907 306907 0 0
Schizophrenia
Mental Health 306908 306908 0 0
Psychosis and personality disorders
Mental Health 307705 307705 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 arms of the study. Both receive CRT. Randomised to receive either SCIT or control group.
Cognitive Remediation Therapy (CRT) - designed to address cognitive deficits by utilising educational software to create a rich learning environment that is intrinsically motivating and rewarding. The treatment will be provided over 10 weeks, 2 times per week. The intervention involves game-based cognitive training with bridging provided in session by trained mental health clinicians (eg. psychologist, occupational therapist, nurse, social worker). The game-based cognitive training is designed specifically for the study as per processes designed by Medalia, Revheim, and Herlands, 2009. The package is made up of freely available games. Attendance to the program will be monitored.
Social cognition and Interaction Training (SCIT) - is a manualised treatment designed to address social cognitive deficits. It consists of 20 one-hour sessions over 10 weeks. Training is run in small groups of three to six people using a manual-driven suite of activities. The training approach of SCIT is such that participants receive repeated exposure and practice of the skills that underlie complex mental-state reasoning abilities. Activities centre on social situations with a focus on making inferences and predictions about the characters’ thoughts, feelings, and behaviours. The group is facilitated by 2 trained mental health clinicians and attendance is monitored for intervention adherence.
Intervention code [1] 301219 0
Treatment: Other
Comparator / control treatment
General Group Therapy - This will be a pragmatic construct used to balance the therapist time for each individual. Participants will be asked to attend another group activity at the centre. This could be made up of a wide range of activities including exercise, art therapy, relaxation or social skills groups. However, they will not be specifically aimed at improving cognition or social cognition.
Control group
Active

Outcomes
Primary outcome [1] 306694 0
Proportion of participants with an improvement in functioning compared to baseline as indicated by the Activity and Participation Questionnaire and the Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [1] 306694 0
Measured at:
Time-point 1 = 1-2 weeks pre-commencement of intervention
Time-point 2 = 22 weeks post commencement of intervention (CRT 10 weeks + 2 weeks break + SCIT or control - 10 weeks)
Time-point 3 = 12 weeks post completion of intervention series (34 weeks) (primary time-point)
Secondary outcome [1] 349278 0
Changes in cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test A & B and the Wechsler Abbreviated Scale of Intelligence II.
Timepoint [1] 349278 0
Measured at:
Time-point 1 = 1-2 weeks pre-commencement of intervention
Time-point 2 = 22 weeks post commencement of intervention (CRT 10 weeks + 2 weeks break + SCIT or control - 10 weeks)
Time-point 3 = 12 weeks post completion of intervention series (34 weeks)
Secondary outcome [2] 349279 0
Changes in social cognitive functioning as measured by the Hinting Task, Penn Emotion Recognition Task (ER-40) and the Ambiguous Intentions Hostility Questionnaire (AIHW)
Timepoint [2] 349279 0
Measured at:
Time-point 1 = 1-2 weeks pre-commencement of intervention
Time-point 2 = 22 weeks post commencement of intervention (CRT 10 weeks + 2 weeks break + SCIT or control - 10 weeks)
Time-point 3 = 12 weeks post completion of intervention series (34 weeks)
Secondary outcome [3] 349280 0
Changes in Quality of life as measured by the Assessment of Quality of Life (AQoL-8D)
Timepoint [3] 349280 0
Measured at:
Time-point 1 = 1-2 weeks pre-commencement of intervention
Time-point 2 = 22 weeks post commencement of intervention (CRT 10 weeks + 2 weeks break + SCIT or control - 10 weeks)
Time-point 3 = 12 weeks post completion of intervention series (34 weeks)

Eligibility
Key inclusion criteria
1. A diagnosis of a severe mental illness and neurocognitive or social cognitive deficits)
2. Are aged 16 – 30 years
3. Able to provide consent (and parent/guardian if required)
4. Have reasonable English skills.
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Developmental delay (IQ < 75)
2.Current substance abuse or substance dependence other than caffeine or nicotine
3. History of head injury (> 10 minutes unconsciousness).
4. Electroconvulsive Therapy in last six months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation Concealment: The sequence will be placed in opaque envelopes and opened centrally by research staff not associated with participant assessment who will remain blind to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/07/2018
Actual
25/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11407 0
Cumberland Hospital - Westmead
Recruitment hospital [2] 11408 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 23313 0
2145 - Westmead
Recruitment postcode(s) [2] 23314 0
2148 - Blacktown
Recruitment postcode(s) [3] 23315 0
2150 - Parramatta
Recruitment postcode(s) [4] 23316 0
2148 - Blacktown Westpoint
Recruitment postcode(s) [5] 23317 0
2750 - Penrith
Recruitment postcode(s) [6] 23318 0
2077 - Hornsby
Recruitment postcode(s) [7] 23319 0
2113 - North Ryde
Recruitment postcode(s) [8] 23320 0
2026 - Bondi
Recruitment postcode(s) [9] 23321 0
2137 - Concord

Funding & Sponsors
Funding source category [1] 299438 0
Government body
Name [1] 299438 0
Western Sydney Local Health District (WSLHD) - Research and Education Network (REN)
Country [1] 299438 0
Australia
Funding source category [2] 301087 0
Government body
Name [2] 301087 0
HETI - Heath Education and Training Institute
Country [2] 301087 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Cnr Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 299494 0
None
Name [1] 299494 0
Address [1] 299494 0
Country [1] 299494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300336 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 300336 0
Ethics committee country [1] 300336 0
Australia
Date submitted for ethics approval [1] 300336 0
19/09/2017
Approval date [1] 300336 0
23/02/2018
Ethics approval number [1] 300336 0
HREC/17/WMEAD/427

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2879 2879 0 0
/AnzctrAttachments/375070-5352 SSA18wmead119 Authorisation Letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 83338 0
Prof Anthony Harris
Address 83338 0
Department of Psychiatry,
Westmead Hospital,
Crn Hawkesbury Road and Darcy Road,
Westmead, 2145, NSW
Country 83338 0
Australia
Phone 83338 0
+61 2 8890 6688
Fax 83338 0
+61 2 86241 389
Email 83338 0
anthony.harris@sydney.edu.au
Contact person for public queries
Name 83339 0
Anthony Harris
Address 83339 0
Department of Psychiatry,
Westmead Hospital,
Crn Hawkesbury Road and Darcy Road,
Westmead, 2145, NSW
Country 83339 0
Australia
Phone 83339 0
+61 2 8890 6688
Fax 83339 0
+61 2 86241 389
Email 83339 0
anthony.harris@sydney.edu.au
Contact person for scientific queries
Name 83340 0
Anthony Harris
Address 83340 0
Department of Psychiatry,
Westmead Hospital,
Crn Hawkesbury Road and Darcy Road,
Westmead, 2145, NSW
Country 83340 0
Australia
Phone 83340 0
+61 2 8890 6688
Fax 83340 0
+61 2 86241 389
Email 83340 0
anthony.harris@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Further consultation about the process is required before the IPD sharing is confirmed


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.